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Ludens Strawberry Banana Throat Drops Pectin 2.8 mg Lozenge, 25-count — NDC 52183-0209-25 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Ludens Strawberry Banana Throat Drops Pectin 2.8 mg Lozenge, 25-count — NDC 52183-209-25 (Billing 52183-0209-25)

by Prestige Brands Holdings, Inc. · 25 LOZENGE in 1 BAG

This is a package of 25 lozenges of Ludens Strawberry Banana Throat Drops Pectin 2.8 mg Lozenge from Prestige Brands Holdings, Inc., no longer marketed (first marketed Jul 2015), no longer in the FDA NDC Directory. It is this product's only package size.

NDC 52183-0209-25
🏷️ FDA NDC (as labeled) 52183-209-25 billing pads the product segment with a zero
OTC Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Sep 2020. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 52183-209-25
Product NDC 52183-209
11-digit billing NDC 52183020925
RxCUI 616469, 637146, 1044442, 1044444
UNII 89NA02M4RX
Application # M022
SPL Set ID adfb248a-96bb-4742-9df6-c47edccdd671
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Sep 2020)
Marketing start 2015-07-01
Route ORAL
Dosage form LOZENGE
Substance PECTIN
Quick answers
  • RxCUI (RxNorm): 616469
Why two NDCs? The FDA registers this code as 52183-209-25 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 52183-0209-25. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Other intestinal adsorbents class.

Drug family (ATC) Other intestinal adsorbents
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

🧪 What is this product?

Ludens Strawberry Banana Throat Drops is an over-the-counter lozenge containing pectin, a natural thickening agent derived from fruit. Pectin is typically used in lozenges and throat drops to coat and soothe the throat and mouth. This product is marketed under FDA's over-the-counter monograph rules for demulcent lozenges, which means it follows established guidelines for this category of oral products rather than undergoing individual FDA review.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
52183-0209-25 You're viewing this Main listing 25 LOZENGE in 1 BAG 2015-07-01 — Discontinued by firm

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Walgreens Wild Cherry Pectin Throat Drops 2.8 mg 00363-9964-90 Walgreens 90 lozenges — — FDA listed —
Walgreens Wild Cherry Throat Drops 2.8 mg 00363-9965-90 Walgreens 90 lozenges — — FDA listed —
CVS Wild Cherry Throat Drop 2.8 mg 51316-0084-20 CVS 120 lozenges — — FDA listed —
Ludens Watermelon Throat Drops 2.8 mg 52183-0202-01 Prestige 25 lozenges — — FDA listed —
Ludens Green Apple Throat Drops 2.8 mg 52183-0204-25 Prestige 25 lozenges — — Discontinued —
Ludens Strawberry Banana Throat Drops 2.8 mgthis 52183-0209-25 Prestige 25 lozenges — — Discontinued —
Ludens Honey Lemon 2.8 mg 52183-0220-25 Prestige 25 lozenges — — Discontinued —
Ludens Wild Cherry Throat Drops 2.8 mg 52183-0229-30 Prestige 30 lozenges — — FDA listed —
Ludens Sugar Free Wild Cherry Throat 2.8 mg 52183-0249-18 Prestige 18 lozenges — — Discontinued —
Ludens Berry Assortment Throat Drops 2.8 mg 52183-0289-30 Prestige 30 lozenges — — Discontinued —
Equate Wild Cherry Throat Drop 2.8 mg 79903-0440-90 Walmart 90 lozenges — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2015
On the market since
Jul 2015
📍
2026
Currently FDA-listed
11 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color red / green / blue
ShapeOval
Imprintludens
Size23 mm
ScoringNot scored
FlavorWatermelon
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 9G5L16BK6N
    A thick, sweet liquid made from corn starch. It acts as a sweetener, thickener, and binder in medicines, helping create the right texture and taste while holding ingredients together.
  • UNII L06K8R7DQK
    A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII 817L1N4CKP
    Malic acid is a naturally occurring organic acid found in fruits. It works as a buffer and flavor agent to maintain the medicine's pH balance and add tartness to the product.
  • UNII 4550K0SC9B
    Sodium acetate is a salt derived from acetic acid. It acts as a buffer to help maintain the medicine's pH stability and may serve as a preservative or solubilizer in liquid formulations.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 241ATL177A
    Soybean oil is a natural plant oil derived from soybean seeds. It's used in medicines as a solvent and carrier to help dissolve or suspend active ingredients and improve how the body absorbs them.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

11 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesascorbic acid, citric acid, corn syrup, FD&C blue no. 1, flavors, malic acid, sodium acetate, sodium chloride, soybean oil, sucrose, water Luden’s Blue   Raspberry Throat Drops Drug Facts ascorbic acid, citric acid, corn syrup, FD&C blue no. 1, flavors, malic acid, sodium acetate, sodium chloride, soybean oil, sucrose, water Luden’s Watermelon Throat Drops Drug Facts ascorbic acid, citric acid, corn syrup, FD&C red no. 40, flavor, malic acid, sodium acetate, sodium chloride, soybean oil, sucrose, water ascorbic acid, citric acid, corn syrup, FD&C red no. 40, flavors, malic acid, sodium acetate, sodium chloride, soybean oil, sucrose, water Luden’s Wild Berry Throat Drops Drug Facts ascorbic acid, citric acid, corn syrup, FD&C blue 1, FD&C blue 2, FD&C red 40, flavors, malic acid, sodium acetate, sodium chloride, soybean oil, and sucrose. Luden’s Wild Cherry Throat Drops Drug Facts Ascorbic Acid, Citric Acid, Corn Syrup, FD&C Blue No. 2, FD&C Red No. 40, Flavors, Malic Acid, Sodium Acetate, Sodium Chloride, Soybean Oil used as a processing aid, Sucrose, Water ascorbic acid, citric acid, corn syrup, FD&C blue no. 2, FD&C red no. 40, flavors, malic acid, sodium acetate, sodium chloride, soybean oil (processing aid), sucrose, water citric acid, corn syrup, FD&C blue no. 2, FD&C red no. 40, FD&C yellow no. 6, flavors, malic acid, sodium acetate, sodium chloride, soybean oil, sucrose, water citric acid, corn syrup, FD&C Blue No. 1, FD&C Yellow No. 5, flavor, malic acid, sodium acetate, sodium choride, sucrose, water

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerPrestige Brands Holdings, Inc.
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code52183
First marketedJul 2015
Product typeHuman Otc Drug
Portfolio42 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 181 words ▾

Uses For temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

Uses For temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

Uses For temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

Uses For temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

Uses for temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

Uses for temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

Uses for temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat

Use s For temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

Uses For temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

Uses For temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

⏱️ Dosage and Administration ~2 min read ▾

Directions A dults and children 3 years of age and older: allow one drop to dissolve slowly in mouth. may be repeated as needed or as directed by a doctor. children under 3 years of age: ask a doctor

Directions A dults and children 3 years of age and older: allow one drop to dissolve slowly in mouth. may be repeated as needed or as directed by a doctor. children under 3 years of age: ask a doctor

Directions a dults and children 3 years of age and older: allow one drop to dissolve slowly in mouth may be repeated as needed or as directed by a doctor children under 3 years of age: ask a doctor

Directions A dults and children 3 years of age and older: allow one drop to dissolve slowly in mouth. may be repeated as needed or as directed by a doctor. children under 3 years of age: ask a doctor

Directions A dults and children 3 years of age and older: allow one drop to dissolve slowly in mouth. may be repeated as needed or as directed by a doctor. children under 3 years of age: ask a doctor

Directions adults and children 3 years of age and older: allow one drop to dissolve slowly in mouth. may be repeated as needed or as directed by a doctor children under 3 years of age: ask a doctor

Directions adults and children 3 years of age and older: allow one drop to dissolve slowly in mouth. may be repeated as needed or as directed by a doctor. children under 3 years of age: ask a doctor

Directions • adults and children 3 years of age and older: allow one drop to dissolve slowly in mouth • may be repeated as needed or as directed by a doctor • children under 3 years of age: ask a doctor

Directions • adults and children 3 years of age and older: allow one drop to dissolve slowly in mouth • may be repeated as needed or as directed by a doctor • children under 3 years of age: ask a doctor

Directions • adults and children 3 years of age and older: allow one drop to dissolve slowly in mouth • may be repeated as needed or as directed by a doctor • children under 3 years of age: ask a doctor

⚠️ Warnings ~3 min read ▾

Warnings Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, consult a doctor promptly. These may be serious. Stop use and ask a doctor if sore mouth does not improve in 7 days irritation, pain or redness persists or worsens. Keep out of reach of children

Warnings Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, consult a doctor promptly. These may be serious. Stop use and ask a doctor if sore mouth does not improve in 7 days irritation, pain or redness persists or worsens. Keep out of reach of children

Warnings Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, consult a doctor promptly. These may be serious. Stop use and ask a doctor if : sore mouth does not improve in 7 days irritation, pain or redness persists or worsens Keep out of reach of children .

Warnings Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, consult a doctor promptly. These may be serious. Stop use and ask a doctor if sore mouth does not improve in 7 days irritation, pain or redness persists or worsens. Keep out of reach of children

Warnings Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, consult a doctor promptly. These may be serious. Stop use and ask a doctor if sore mouth does not improve in 7 days irritation, pain or redness persists or worsens. Keep out of reach of children

Warnings Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, consult a doctor promptly. These may be serious. Stop use and ask a doctor if sore mouth does not improve in 7 days irritation, pain or redness persists or worsens Keep out of reach of children .

Warnings Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, consult a doctor promptly. These may be serious. Stop use and ask a doctor if sore mouth does not improve in 7 days irritation, pain or redness persists or worsens Keep out of reach of children .

Warnings Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, consult a doctor promptly. These may be serious. Stop use and ask a doctor if • sore mouth does not improve in 7 days • irritation, pain or redness persists or worsens Keep out of reach of children

Warnings Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, consult a doctor promptly. These may be serious. Stop use and ask a doctor if • sore mouth does not improve in 7 days • irritation, pain or redness persists or worsens Keep out of reach of children

Warnings Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, consult a doctor promptly. These may be serious. Stop use and ask a doctor if • sore mouth does not improve in 7 days • irritation, pain or redness persists or worsens Keep out of reach of children

🧪 Active Ingredient 84 words ▾

Active ingredient (in each drop) Pectin 2.8 mg

Active ingredient (in each drop) Pectin 1.7 mg

Active ingredient (in each drop) Pectin 2.8 mg

Active ingredient (in each drop) Pectin 1.7 mg

Active ingredient (in each drop) Pectin 2.8 mg

Active ingredient (in each drop) Pectin 1.7 mg

Active ingredient (in each drop) Pectin 2.8 mg

A ctive ingredient (in each drop ) Pectin 1.7 mg

A ctive ingredient (in each drop ) Pectin 2.8 mg

Active ingredient (in each drop) Pectin 2.8 mg

🧪 Inactive Ingredients ~1 min read ▾

Inactive ingredients ascorbic acid, citric acid, corn syrup, FD&C blue no. 1, flavors, malic acid, sodium acetate, sodium chloride, soybean oil, sucrose, water Luden’s Blue Raspberry Throat Drops Drug Facts

Inactive ingredients ascorbic acid, citric acid, corn syrup, FD&C blue no. 1, flavors, malic acid, sodium acetate, sodium chloride, soybean oil, sucrose, water Luden’s Watermelon Throat Drops Drug Facts

Inactive ingredients ascorbic acid, citric acid, corn syrup, FD&C red no. 40, flavor, malic acid, sodium acetate, sodium chloride, soybean oil, sucrose, water

Inactive ingredients ascorbic acid, citric acid, corn syrup, FD&C red no. 40, flavors, malic acid, sodium acetate, sodium chloride, soybean oil, sucrose, water Luden’s Wild Berry Throat Drops Drug Facts

Inactive ingredients ascorbic acid, citric acid, corn syrup, FD&C blue 1, FD&C blue 2, FD&C red 40, flavors, malic acid, sodium acetate, sodium chloride, soybean oil, and sucrose. Luden’s Wild Cherry Throat Drops Drug Facts

Inactive ingredients Ascorbic Acid, Citric Acid, Corn Syrup, FD&C Blue No. 2, FD&C Red No. 40, Flavors, Malic Acid, Sodium Acetate, Sodium Chloride, Soybean Oil used as a processing aid, Sucrose, Water

Inactive ingredients ascorbic acid, citric acid, corn syrup, FD&C blue no. 2, FD&C red no. 40, flavors, malic acid, sodium acetate, sodium chloride, soybean oil (processing aid), sucrose, water

Inactive ingredients citric acid, corn syrup, FD&C blue no. 2, FD&C red no. 40, FD&C yellow no. 6, flavors, malic acid, sodium acetate, sodium chloride, soybean oil, sucrose, water

Inactive ingredients citric acid, corn syrup, FD&C blue no. 2, FD&C red no. 40, FD&C yellow no. 6, flavors, malic acid, sodium acetate, sodium chloride, soybean oil, sucrose, water

Inactive ingredients citric acid, corn syrup, FD&C Blue No. 1, FD&C Yellow No. 5, flavor, malic acid, sodium acetate, sodium choride, sucrose, water

🎯 Purpose 30 words ▾

Purpose Oral demulcent

Purpose Oral demulcent

Purpose Oral demulcent

Purpose Oral demulcent

Purpose Oral demulcent

Purpose Oral demulcent

Purpose Oral demulcent

Purpose Oral demulcent

Purpose Oral demulcent

Purpose Oral demulcent

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Pectin — the ingredient across all brands.

Top reported reactions

Fatigue15
Cough12
Diarrhoea11
Headache10
Nausea9
Anxiety8
Abdominal Pain7

Age at onset

Adult7
Elderly8

Reporter sex

0 reports

Serious outcomes

Hospitalization42
Life-threatening9
Death6
Disabling3
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 9 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Who lists this product with the FDA?
Prestige Brands Holdings, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 52183-0204-25 · Prestige 52183-0220-25 · Prestige →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.